Keeping Pace with Customers: One Instrumentation and Testing Company Says Evolution Is Key

As medical devices and pharmaceuticals grow ever more sophisticated and complex, their sensitivity to the environment tends to increase. Minneapolis-based MOCON Inc., a manufacturer of testing instrumentation and provider of laboratory and consulting services exhibiting at MD&M West again this year, understands sophisticated products and their environmental vulnerabilities and makes it a point to improve the sensitivity of its tests and instruments accordingly.

One such MOCON instrument, the Ox-Tran Model 2/21 10x oxygen-transmission-rate test system, features an improved proprietary Coulox coulometric sensor that offers unusually high sensitivity, MOCON’s manager, business development medical/pharma Ed Emerson says, by counting each and every individual oxygen molecule permeating through a film or package. This instrument “shows an ongoing effort to not only meet but exceed the needs of our healthcare customers for increased sensitivity, more sophisticated testing, and efficacy,” Emerson says. “In the pharma and medical-device industries, permeability testing in general has been around for decades. What we’ve been experiencing in recent years, though, is increased interest in the subject, because the materials—polymers, plastics, and other types of elastomers—that are being used in products today are much more sophisticated,” he explains. “This greater sophistication, by definition, leads to these concerns, especially when you have sensitive drugs, or a biologic, or some kind of agent of the device or a combination product whose efficacy, safety, and shelf life are subject to the materials that are part of the overall structure, device, or apparatus.”

The OpTech O2 Platinum system tests both whole medical devices and critical subcomponents.

Likewise, MOCON’s “disruptive technology,” as Emerson describes it, is the Op-Tech O2 Platinum, which combines a fluorescent optical light reaction with a platinum reactive optical sensor to determine how much oxygen is in an enclosed area: a tiny little blister pack for a capsule, for example, or a larger area like a pouch housing a large device. This instrument measures oxygen without breaching the package or changing the package’s environment in any way.

Oxygen is, of course, only one of many environmental elements of concern to healthcare-product and -packaging customers. Carbon dioxide, moisture, light, and sterilization can all degrade or damage products as well. For measuring permeability to water vapor, for example, MOCON offers its PERMATRAN-W line of equipment. “Moisture can be just as destructive as oxygen,” Emerson says, “so those two threats are the core of our permeation systems. We also receive frequent requests for other air gases or volatile permeants, which may be equally critical to medical products.”

Additionally, Emerson says, he is seeing more customers thinking about ways, when they seal up their package, to evacuate the room air that gets trapped inside of it. “Once you seal your pouch up, that trapped air begins degrading your product from day 1,” he explains. MOCON is meeting that particular challenge with modified atmosphere packaging (MAP), a technology that incorporates a gas flush into a sealed nonporous package. MAP “purges the oxygen and other room air gases from the package and puts in dry nitrogen, for example, which starts the package off as a much happier environment for that product,” Emerson explains.

Higher Stakes, Greater Pressures
Healthcare-industry customers face greater economic, time-to-market, and regulatory pressures than do customers in other industries, which in turn makes them better candidates for full-service testing and evaluation programs than customers in less complicated industries. “A great number of medical device companies have fewer than 10 people,” Emerson points out. “And often, these companies don’t have the lab capability in house, they don’t have the expertise, they don’t have the knowledge of how to set up and execute a study using permeability. They can come to [a company like MOCON] for basic testing, or they can outsource an entire study, such as a shelf-life modeling study, that will answer such questions as, ‘How will this product perform in various environments with these resins, these agents, and these ingredients?’” This type of full-scale service can be used by healthcare clients for R&D as well as for quality-control testing. “They don’t have to just extrapolate from the pristine sample of the individual film or resin. They can test their finished product and challenge it in the same ways that the actual environment would challenge their device or package,” Emerson says.